UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the anti UV-induced inflammation effect of a plant extract ingredient. (Randomized, double-blind, placebo-controlled, parallel-group study)
Title of the study (Brief title)	Verification of the anti UV-induced inflammation effect of a plant extract.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare and investigate the suppressive effect on UV-induced inflammation before and after the consumption of a test food, using placebo as control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Minimal Erythema Dose Minimal Tanning Dose Skin color (L*, a*) on the UV-irradiated region. Stratum corneum hydration and Transepidermal water loss on the UV-irradiated region.
Key secondary outcomes	Skin color (L*, a*) Stratum corneum hydration Transepidermal water loss

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	once a day for five weeks
Interventions/Control_2	Placebo capsule once a day for five weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	1) Men and women aged >= 30 to <50 years 2) Those fall under the category of Fizpatrick skintype II
Key exclusion criteria	1) Those with a diagnosis of photosensitive disorder. 2) Those who take drugs which affect skin photosensitivity. 3) Those with diagnosis of diseases on the measurement region by a medical advice. 4) Those whose MED was not detected in the measurements. 5) Those who have treated for beauty on the measurement region. 6) Those who routinely take foods, supplements and cosmetics that contain the same active ingredient. 7) Those who have treated for special skincare on the mesurement region or who have a plan to have the treatment within past 4 weeks. 8) Those who changed healthy foods or external preparation including basic skin-care products that use for measurement region, or who have begun usage of them within past 4 weeks. 9) Those who was exposed to exceeded UV-light than in daily life by activities including long hours of outwork, sports, sea bathing and leisure activities, or who have a plan it during the study period. 10) Those who engage in the night work and work in shifts day and night. 11) Those who are receiving the treatments to treat or prevent disease at medical institution at the time of receiving informed consent, or who have need of those therapy. 12) Those who have serious disorders of carbohydrate metabolism, lipid metabolism, liver function, kidney function, heart, cardiovascular, respiratory organs, endocrine system and nervous system, or with a history of psychiatric disorder. 13) Those with a history of alcoholic and drug dependency. 14) Those with allergies to cosmetics or foods. 15) Pregnant women, those who may be pregnant, lactating women at the time of receiving informed consent, or women who hope to become pregnant during the study period. 16) Those who have participated in other human studies similar to the study within past 2 months. 17) Those who have participated in other human studies within the past 4 weeks, or who plan to participate. 18) Those who were considered inappropriate for the study by an investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	Takeshi Takaha
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Health Sciences, Material Science Group
Address	4-6-5 Utajima, Nishiyodogawa, Osaka 555-8502, JAPAN
TEL	06-6477-8425
Email	takaha-takeshi@glico.co.jp

Public contact
Name of contact person	Takahiro Hemmi
Organization	Matsumoto Trading Co., Ltd.
Division name	Safety Study Trust Dept.
Address	1-13-7, Nihonbashi-Muromachi, Chuo-ku, Tokyo, Japan
TEL	03-3241-5162
Homepage URL
Email	hemmi.takahiro@matsumoto-trd.co.jp

Sponsor
Institute	Ezaki Glico Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 15 Day
Anticipated trial start date	2016 Year 09 Month 27 Day
Last follow-up date	2016 Year 11 Month 08 Day
Date of closure to data entry	2017 Year 03 Month 27 Day
Date trial data considered complete	2017 Year 03 Month 27 Day
Date analysis concluded	2017 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2017 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027645